Intermediate Course for Regulatory Submissions in eCTD Format–April 2017

If you are currently preparing CTD submissions for the FDA submissions and are familar with the CTD structure, but need to learn how to comply with the May 2017 electronic submission requirements, this course is for you.

The deadline is fast approaching for your company to migrate to electronic-only regulatory submissions based on the required ICH eCTD format. To successfully meet the new requirements, organizations need to understand the processes needed to build electronic submissions and implement operational changes that will lead to successful electronic regulatory applications. During this workshop, you will learn:

  • Which types of applications need to be submitted electronically
  • How to comply with the May 2017 electronic submissions requirements
  • Which agency guidelines and technical specifications publishers need to follow
  • How to apply ICH and regional requirements to your eCTD
  • How to compile documents into the XML backbone of an eCTD, and lifecyclethat application
  • How to QC and validate an eCTD
  • How metadata and study tagging files work
  • Tips, tricks and best practices gathered from industry professionals
  • Converting from a paper application to an eCTD
  • What CTD readiness really means

We will also provide an overview of the difference submissions to US and Rest of the World (ROW), and help you understand how to prepare for each region.

Join us for this intense two-day, hands-on compilation training that will answer your submission questions and help you get on a direct path to compliance.




  • At a Glance
  • Objectives & Audience
  • Agenda
  • Faculty
  • Registration Info
  • Cancellation

At a Glance

Date:

12 April 2017 (9:00 am–4:30 pm EST), 13 April 2017 (9:00 am–3:00 pm EST)

Meeting Location:

US Pharmacopeial Convention
12601 Twinbrook Parkway
Rockville, MD

Registration Closes:

6 April 2017

Refund Deadline:

5 March 2017

RAC Credits:

10 

Will this meeting be recorded?

No

Proof of Attendance:

An electronic letter of attendance will be sent upon request.

Registration Fees:

Registration to 5 February 2017
RAPS Members:  $1,350

Government:  $1,450

 

Registration from 6 February to 6 March 2017
RAPS Members:  $1,450

Government:  $1,550 

 

NOTE: Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 40 people

» More Meeting FAQs

Objectives

At the conclusion of this program, participants will be able to:

  • Identify best practices with software used to generate electronic submission content
  • Understand the acronyms and terms surrounding eCTD and electronic submissions
  • Apply ICH and regional requirements for the content of an eCTD submission
  • Produce and review eCTDs to minimize the chance of Refusal to Review and Refuse to File (RTF) actions by FDA
  • Discuss Canadian and EU submissions and procedures and how eCTDs for these regions differ from the US
  • Obtain an understanding of what is required to transition into submitting in the eCTD format

Who Should Attend

This intermediate level course is for people who have a working knowledge of the CTD format and are already preparing documents for FDA submissions. The program is intended to be a boot camp for regulatory professionals who need to gain basic knowledge in eCTD submissions to meet the fast-approaching FDA electronic submission deadlines in May 2017. 

This workshop is beneficial for professionals working in the drugs, biologics or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, regulatory operations, and submissions publishing.

Agenda

Agenda

  • How to comply with the May 2017 electronic submission requirement
  • Guidances that govern electronic submissions
  • ICH and Regional requirements: US with introduction to Rest of World (ROW) differences
  • How to electronically submit to Health Authorities: US, Canada, and Europe
  • Generating compliant PDF files—best practices in MS Word and Adobe Acrobat
  • Hands-on compilation of an eCTD
    • Module 1 differences for the US, Canada, and EU
    • Creating the initial sequence of an application
    • Assigning the metadata required by the regional authority and ICH
    • Lifecycling the application
  • Compiling:
    • Datasets
    • eDMFs (electronic Drug Master Files)
    • Safety reports
    • SPLs (Structured Product Labeling)
  • Granulated Clinical Study Reports (gCSR)
  • Challenges with preparing compliant eCTD submissions
  • Review and QC of the compiled application
  • Validation and deciphering validation error codes
  • Common and avoidable errors that could get your submission rejected
  • The new Module 1 for marketing/advertising 2253 submissions 
  • Tips, tricks and best practices gathered from industry professional
  • Converting from a paper application to an eCTD application
  • Recommendation for planning and tracking the workflow of your eCTD
  • What eCTD readiness really means

    NOTEProgram content may vary.  

    NOTE: Laptops are required. RAPS does supply laptop equipment for attendees. 

     

    Faculty

    Elsmari Eggers, head of training and RA consulting, LORENZ Life Sciences
    Nora Keeling, MS, consultant, Mentara Inc.
    Jared Lantzy, PMP, manager, global regulatory agencies and processes, LORENZ Life Sciences, and former member of the FDA electronic submission support team
    Marianne Mowrer, regulatory submissions specialist, Mentara Inc.

    Registration Info

    IMPORTANT: Attendees must bring their own laptops. RAPS does not provide equipment for attendees.  

     

    Registration to 5 February 2017
    RAPS Members:  $1,350
    List:  $1,450


    Registration from 6 February to 6 April 2017

    RAPS Members:  $1,450
    List:  $1,550

     

    Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted. Seating for the program is limited to 35 people. 

     

    » Registration Online
    » Registration Form (PDF) - for registration by mail or fax

    If it is your preference, please use the registration form to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer.


    Questions? Call RAPS Solutions Center at +1 301 770 2920, ext. 200.

    Refund Deadline: 5 March 2017

    Other Information
    RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

    Program Contact

    Chris Hall
    chall@raps.org
    +1 301 770 2920, ext. 222 

    Parking
    Paid parking is available in the parking building directly behind 5635 Fishers Lane in Rockville (next door to US Pharmacopeial Convention).

    Area Airports
    Ronald Reagan Washington National Airport (24 miles) 
    Washington Dulles International Airport (36 miles)
    Baltimore-Washington International Airport (37 miles)

    Area Hotels
    The following hotels are located near US Pharmacopeial Convention.

    Even Hotel Rockville (Walking Distance)
    1775 Rockville Pike
    Rockville, MD 20852
    Reservations: +1 877 834 3613

    Hilton Washington DC/Rockville Hotel (Walking Distance) 
    1750 Rockville Pike
    Rockville, MD 20852
    Reservations: +1 301 468 1100

    Bethesda North Marriott Hotel
    701 Marinelli Road
    Bethesda, MD 20852
    Reservations: +1 301 822 9200

    Bethesda Marriott Suites
    6711 Democracy Boulevard
    Bethesda, MD 20817
    Reservations: +1 800 228 9290

    Washington Metro Access
    The Twinbrook Metro Station is a short walk to 12601 Twinbrook Parkway. Take the Red Line to the Twinbrook Metro Station.

    Cancellation

    All cancellation requests must be submitted to raps@raps.org by 5 March 2017. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed. 

    Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 5 March 2017. 

    If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.

    NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.